FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

ANESTHESIA BREATHING CIRCUIT

K Number: K900594 · Decision Mar 15, 1990
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
7
Review Days
36

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Basic Information

Device Name
ANESTHESIA BREATHING CIRCUIT
K Number
K900594
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5240
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Inhalation Plastics
Date Received
February 7, 1990
Decision Date
March 15, 1990
Product Code
CAI
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

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K945565 SPIRO-FLEX
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K901315 AEROMIST II NEBULIZER
K900990 FILT-R-ALL BACTERIAL/VIRAL FILTER
K896832 FILT-R-ALL BACTERIAL FILTER
K874659 STERILIZATION OF DEVICES BY RADIATION